joey@mothersagainstmedicalabuse.org

 

 

 

DISCLAIMER

Dr. Danger is intended as an educational and supplemental information site to inform the general public, consumer, and patients taking medications/products, of new drug information as it becomes available, product warnings and recalls, emerging drug events and adverse reports, early warning system from consumers/patients using drugs/products experiencing adverse or untoward reactions or events associated with their medication/products. We will also report of drugs on the illicit front causing serious harm, reactions, or emerging events. Emerging events as reported by the consumer/patients, may not be investigated and are the reactions/events of that patient/consumer, we assume no responsibility for information posted here as it is the report of that person. We assume no responsibility for information posted on this site as this is only supplemental information to you and is not intended as a substitute for professional information from your physician, pharmacist, or other professional healthcare provider.
This information is intended to be supplemental information for the consumer/patient using medication and over-the-counter products, and is not intended to substitute, the expertise and judgment of your physician, pharmacist or other healthcare professional. It is not implied to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug and any medication prior to its use. Any concerns, problems or reactions to any medication or product should be reported immediately to your healthcare provider. If you should have any adverse or allergic reaction to any medication or product, contact 911 or your local EMS immediately without any delay, as this can be a life threatening condition.

 

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     OTC DRUG RECALL (XIADAFIL VIP TABLETS)

Recall-OTC CONSUMER ALERT AND PRESS RELEASE

FOR IMMEDIATE RELEASE
May 27, 2008

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Requests Recall of Xiadafil VIP Tabs
Product contains undeclared ingredient that puts consumer health at risk
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).
Today's formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. The agency may take further regulatory action to protect consumers from this illegal product.
Although labeled as a dietary supplement and touted as "all-natural," Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient. FDA chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.
This undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions.
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DRUG RECALL (SOLODYN 90MG-EXTENDED RELEASE (MINOCYCLINE HCL,USP)

Recall-CONSUMER ALERT AND PRESS RELEASE

Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up
Contact:
Stericycle Customer Service
1-888-656-6381
FOR IMMEDIATE RELEASE -- SCOTTSDALE, Ariz. -- May 16, 2008 -- Medicis today announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market.
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DRUG REMOVAL FROM MARKET (Trasylol)

Removal of Drug-CONSUMER ALERT AND PRESS RELEASE

FOR IMMEDIATE RELEASE
May 14, 2008

Media Inquiries:
Peper Long, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

Manufacturer Removes Remaining Stocks of Trasylol
Access Limited to Investigational Use
Background: On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide Trasylol through this mechanism for the limited use described above.
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OTC RECALL (Cardinal Health labeled alcohol-free mouthwash) Hospital and Long Term Care Facilities)

Recall-OTC-CONSUMER ALERT AND PRESS RELEASE

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

Contact:
Cardinal Health
800-292-9332
FOR IMMEDIATE RELEASE -- Elgin, IL -- May 16, 2008 Hydrox Labs, Elgin, IL has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a voluntary sub recall of this lot of alcohol-free mouthwash. The FDA has been apprised of the action. The mouthwash was tested, and certain samples were found positive for Burkholderia cepacia (B. cepacia).
Product was distributed to hospitals, medical centers, and long term care facilities nationwide.
B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF) or on mechanical ventilators, may be more susceptible to infections with B. cepacia. B. cepacia is a known cause of infections in hospitalized patients. B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.
The recall includes the following products:

Description
Cardinal Label Reorder Number
Lot Number

Alcohol-Free Mouthwash, Cardinal Health, 4 oz.
AG-210
26230

Affected product can be identified by checking the lot number stamped on the Cardinal Health label. The Lot number is located on the side of the bottle.
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DRUG RECALL (DIGITEK - DIGOXIN TABLETS, USP)

Recall-CONSUMER ALERT AND PRESS RELEASE
MOTHER'S AGAINST MEDICAL ABUSE® and Dr. Danger ® posts FDA press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. We do not endorse either the product or the company.

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution
Contact:
Stericycle customer service
1-888-276-6166
FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.
Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.
This recall is being conducted with the knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
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OTC DRUG RECALL -MULTIPLE PRODUCTS (RECALL OF 12 DIETARY SUPPLEMENTS)

Recall-CONSUMER ALERT AND PRESS RELEASE

Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta
Contact:
Ginger Chang
(626) 333-9998
FOR IMMEDIATE RELEASE -- City of Industry, CA--April 10, 2007- Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.
FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury. The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands:
Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San
Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the United States.
All of the twelve products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.
Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund. Consumers with questions may contact the company at (626) 333-9998. Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
No illnesses have been reported to the company to date in connection with these products and the company has ceased distribution of all of these products.
.
Herbal Science International, Inc. apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.
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DRUG SAFETY/WARNING CHANGES - (Relenza - zanamivir)

Relenza (zanamivir)

[Posted 04/01/2008] GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.

Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

MARCH 11, 2008

GlaxoSmithKline
Three Franklin Plaza
P.O. Box 13619
IMPORTANT PRESCRIBING INFORMATION
Philadelphia, PA
19101-3619
Tel. 215 751 4000 Fax. 215 751 3400 www.gsk.com

GlaxoSmithKline would like to advise you of a recent update to the RELENZA (zanamivir) Inhalation Powder package insert. The revision to the product label is a result of information about adverse events reported during postmarketing clinical use of RELENZA.
The revised WARNINGS AND PRECAUTIONS section of the RELENZA Inhalation Powder package insert now includes the following information and guidance under a new Neuropsychiatric Events subheading:
Neuropsychiatric Events
Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including RELENZA. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon based on usage data for RELENZA. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of RELENZA to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

Additionally, we would like to direct you to the proceedings and discussion of these adverse events
by the Pediatric Advisory Committee on November 27, 2007 at http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4325t1_transcript.pdf. GlaxoSmithKline will continue to monitor the safety of RELENZA through established reporting mechanisms and notify regulatory authorities of any serious adverse events for evaluation. We will continue to provide you with the most current product information for RELENZA moving forward. You can assist us in monitoring the safety of RELENZA by reporting adverse reactions to us at 1888-825-5249, or to FDA at www.fda.gov/medwatch, or by mail to MedWatch, Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd.Beltsville, MD 20705-1266.

Safety Information
RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease).
Serious cases of bronchospasm, including fatalities, have been reported during treatment with RELENZA in patients with and without underlying airways disease. Many of these cases were reported during postmarketing and causality was difficult to assess.
RELENZA should be discontinued in any patient who develops bronchospasm or decline in respiratory function; immediate treatment and hospitalization may be required.
Some patients without prior pulmonary disease may also have respiratory abnormalities from acute respiratory infection that could resemble adverse drug reactions or increase patient vulnerability to adverse drug reactions.
Bronchospasm was documented following administration of zanamivir in 1 of 13 patients with mild or moderate asthma (but without acute influenza-like illness) in a Phase I study. In a Phase III study in patients with acute influenza-like illness superimposed on underlying asthma or chronic obstructive pulmonary disease, 10% (24 of 244) of patients on zanamivir and 9% (22 of 237) on placebo experienced a greater than 20% decline in FEV1 following treatment for 5 days.
If use of RELENZA is considered for a patient with underlying airways disease, the potential risks and benefits should be carefully weighed. If a decision is made to prescribe RELENZA for such a patient, this should be done only under conditions of careful monitoring of respiratory function, close observation, and appropriate supportive care including availability of fast-acting bronchodilators.
Do not use in patients with history of allergic reaction to any ingredient of RELENZA including lactose (which contains milk proteins).
Allergic-like reactions, including oropharyngeal edema, serious skin rashes, and anaphylaxis have been reported in postmarketing experience with RELENZA. RELENZA should be stopped and appropriate treatment instituted if an allergic reaction occurs or is suspected.
Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring inpatient management.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. RELENZA has not been shown to prevent such complications.
Effective and safe use of RELENZA requires proper use of the DISKHALER to inhale the drug. Prescribers should carefully evaluate the ability of young children to use the delivery system if use of RELENZA is considered.
The most common adverse events reported in >1.5% of patients treated with RELENZA and more commonly than in patients treated with placebo are:

Treatment Studies – sinusitis, dizziness.
Prophylaxis studies – fever and/or chills, arthralgia and articular rheumatism.
The concurrent use of RELENZA with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of RELENZA, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of RELENZA.
Sincerely,
Judith Ng-Cashin, M.D. Director, GlaxoSmithKline
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DRUG RECALL-Covidien (HEPARIN SODIUM, USP, PRE-FILLED SYRINGES)

Recall-CONSUMER ALERT AND PRESS RELEASE
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin

Heparin Sodium USP Pre-Filled Syringes

[Posted 04/02/2008] Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.

Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin
Contact:
Eric Kraus
508-261-8305
FOR IMMEDIATE RELEASE -- MANSFIELD, Massachusetts – March 28, 2008 - Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. The voluntary recall affects the following 32 lots manufactured and distributed by Covidien in the United States.
Product
Lot Numbers

REF # 8881580121
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 10mL
7082274
7113214

REF # 8881580123
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 3mL
7051524
7113214

REF # 8881580125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL
7051524
7082274
7113164
7113174

REF # 8881580300
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe
2.5mL in 3mL syringe
7051444

REF # 8881581125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082274

REF # 8881590121
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 10mL
7113064

REF # 8881590123
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 3mL
7041194
7072154
7113034
8010194

REF # 8881590125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL
7041194
7102804
7041204
7113034
7051534
7113044
7051544
7113054
7051554
7113104
7071924
7113114
7072034
7113154
7072044
8010064
7072054
8010114
7072064
8010134
7072154
8010174
7082284

REF # 8881591125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula
7082284

Covidien began recalling the lots today as a precautionary measure. This product recall was initiated due to a notification received from the supplier, SPL, disclosing that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the Company is committed to following the direction of the Food and Drug Administration (FDA) regarding this matter.
The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.
Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178
Customers who have product in their possession from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers with questions about the return of recalled product should contact the Return Coordinator at 1-800-346-7197, ext. 8677, between 8:30am – 5:00pm (ET), Monday through Friday.
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DRUG RECALL (NEUPRO -ROTIGOTINE TRANSDERMAL SYSTEM)

Neupro (rotigotine transdermal system)

[Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, at the end of April 2008, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.

UCB, Inc. - 1950 Lake Park Drive – Smyrna, Georgia 30080 Neupro® is a registered trademark of UCB SA or its affiliates Tel. (770) 970-7500 – Toll Free (800) 477-7877 – www.ucb-group.com March 21, 2008

Neupro® patients - please consult your physician as soon as possible

Dear Patient,

Neupro® (rotigotine transdermal system) patches are being recalled in the United States and will not be available after the end of April 2008. The Neupro® patch is a transdermal delivery system worn on the skin and is used to treat early stage Parkinson’s disease. It is made by Schwarz Pharma, a company of the UCB group.

You should take the following steps:

1. Do not stop taking Neupro without first talking to your doctor

2. Consult your physician as soon as possible

Your doctor will instruct you on how to gradually come off Neupro – this may take several days, depending on your current dose.

Some Neupro patches have snowflake-like patterns on them. The more snowflakes you see, the less likely it is that the patch will work properly.

Please refer to the pictures of patches on the back of this letter:

• Patches with no snowflakes can be used.

• Patches that look like picture A can be used.

• Patches that look like picture B should not be used.

Contact your doctor if you have any questions about your medication or this letter. You may also contact UCB medical information directly at 1-800-477-7877 (option 9) if you have any questions.

Thank you for your understanding. We sincerely apologize for the inconvenience this may cause you.

Sincerely,

Kathleen Bos, MD

Vice President, U.S. Medical Affairs
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DRUG SAFETY/WARNING CHANGES -(EXUBERA-INSULIN hUMAN Rdna ORIGIN)

Exubera (insulin human rDNA origin) Inhalation Powder

[Posted 04/09/2008] Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.

Re: Important Safety Information About Exubera® (insulin human [rDNA origin]) Inhalation Powder
Based on an ongoing review of the Exubera clinical data and post-marketing reports by Pfizer and the Food and Drug Administration (FDA), Pfizer has updated the Exubera prescribing information and Medication Guide to highlight safety information you should know and should discuss with your doctor.
What do you need to know?
You should be aware that in studies of Exubera in people with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All the people in these studies who developed lung cancer used to smoke cigarettes. There were too few cases to know if the lung cancer was related to Exubera.
What else should you know about diabetes and Exubera?
Do not stop taking Exubera without first discussing this with your doctor. Exubera is a safe and effective medicine.
As with all forms of insulin, a possible side effect of EXUBERA is low blood sugar (hypoglycemia), which can be mild to severe. It is important to check your blood sugar as your health care provider has advised you. Other common side effects are cough, dry mouth and chest discomfort.
This information does not take the place of talking with your doctor about your condition or treatment. Please speak with your doctor about any questions or concerns you may have.
Sincerely,
Rochelle L. Chaiken, MD Vice President, Global Medical Cardiovascular and Metabolic Diseases Pfizer Inc
Encl: Updated Prescribing Information and Medication Guide
EXUBERA is a prescription medicine that you breathe in through your mouth using the EXUBERA® Inhaler. It is a short-acting insulin that helps to control high blood sugar in adults with diabetes. If you have Type 1 diabetes, you will have to take longer-acting insulin in addition to EXUBERA. If you have Type 2 diabetes, you may use EXUBERA by itself, or with diabetes pills. Some patients with Type 2 diabetes will need to take some longer-acting insulin in addition to EXUBERA.
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DRUG SAFETY/WARNING CHANGES -(SINGULAIR-montelkast)
*POSSIBLE SUICIDE RISK*

Singulair (montelukast)

FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Early Communication About an Ongoing Safety Review of Montelukast (Singulair)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.
Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).
In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescribers and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and provide prescribers with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).
FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.
Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Singulair is an effective medicine that is indicated for the treatment of asthma and symptoms of allergic rhinitis. Patients should not stop taking Singulair before talking to their doctor if they have questions about this new information. Until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program

on-line at [www.fda.gov/medwatch/report.htm];
by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
faxing the form to 1-800-FDA-0178; or
by phone at 1-800-332-1088
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DRUG RECALL -DANGEROUS DRUG -(B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

[Posted 03/21/2008] B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

[March 21, 2008 - B. Braun Medical]

B. Braun’s Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions
Scientific Protein Laboratories LLC (SPL) manufactures Heparin Sodium USP active pharmaceutical ingredient that is used by B. Braun Medical Inc. to produce Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride injection solution
Contact:
Stephanie Euler, 908-276-4344 ext. 213
Susan Denby, 610-997-4856
FOR IMMEDIATE RELEASE --Irvine, CA -- March 21, 2008 --- B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.
B. Braun FP Lot #

B. Braun FP Material
Description
NDC Numbers
CAN DIN

J7D490
P5872
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
0264-9587-20
N/A

J7C684
P5771
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
0264-9577-10
N/A

J7D496
P5771
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
0264-9577-10
N/A

J7C470
P5872
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
0264-9587-20
N/A

J7D580
P5671-00
Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL)
N/A
02209713

J7E420
P5872-00
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
N/A
02209721

J7C611
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7C557
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7C477
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7C705
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7D485
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7E415
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7E416
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7E494
P5872
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
0264-9587-20
N/A

J7E500
P5771
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
0264-9577-10
N/A

J7E577
P5771-00
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
N/A
01935941

J7E489
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7N556
P5872
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
0264-9587-20
N/A

J7P404
P5771
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
0264-9577-10
N/A

J7N604
P5771
Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
0264-9577-10
N/A

J7P476
P5872
Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
0264-9587-20
N/A

J7N519
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

J7N676
P8721
Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
0264-9872-10
01935933

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue.
The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.
Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178
Adverse reactions or quality problems experienced in Canada with use of this product may be reported to Health Canada. For details on how to report these reactions please refer to the following website:

Online: http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index_e.html
Customers who have product in their possession from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers may contact B. Braun Medical Inc. Customer Support Department at (800) 227-2862 for U.S. and (800) 624-2920 for Canada, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
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DEVICE RECALL - (Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps )

Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps

FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps.

[March 21, 2008- FDA]

Class I Recall: Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
Date Recall
Initiated January 16, 2008

Product: Medtronic Neuromodulation Implantable Infusion Pumps:

SynchroMed EL Implantable Infusion Pump, Models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, 8627L-18
SynchroMed II Implantable Infusion Pump, Models 8637-20, 8637-40,
IsoMed Implantable Infusion Pump, Models 8472-20, 8472-35, 8472-60.
The implantable components of the infusion systems listed above include the pump, a side catheter access port, catheters, and/or catheter accessories.
Use: These devices administer drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories.

Recalling Firm: Medtronic Neuromodulation
800 53rd Avenue NE
Minneapolis, Minnesota 55440-1250
Reason for Recall: The company updated the labeling for the devices to include current patient management and treatment recommendations. The company also received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. For more detailed information, please see the link below to the company’s press release.

Public Contact: Patients or customers may contact Medtronic Neuromodulation at 1-800-707-0933 from Monday - Friday, 7:00 a.m. – 6:00 p.m. (Central Standard Time) or by emailing the company at: http://www.medtronic.com/corporate/contact.jsp

FDA District: Minneapolis
FDA Comments: On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps.
For more information about this recall, including Medtronic's letter to physicians, please see the company’s press release at: http://wwwp.medtronic.com/Newsroom/ NewsReleaseDetails.do?itemId=1205958103681
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Online:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
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UPDATED DRUG SAFETY AND WARNING- (SPIRIVA HANDIHALER)

Tiotropium (marketed as Spiriva HandiHaler)

Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.

It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

[March 18, 2008- FDA]

Early Communication about an Ongoing Safety Review of Tiotropium
(marketed as Spiriva HandiHaler)

This information reflects FDA’s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
The manufacturer of Spiriva HandiHaler, Boehringer Ingelheim, recently informed the FDA that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take this medicine. Spiriva HandiHaler contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD). Additional information is needed to further evaluate this preliminary information about stroke in patients who take Spiriva HandiHaler.
Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). In 25 of the clinical studies, patients were treated with Spiriva HandiHaler. In the other 4 clinical studies patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat. The 29 clinical studies included approximately 13,500 patients with COPD. Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.
It is important to interpret these preliminary results with caution. FDA has not confirmed these analyses. Pooled analyses can provide early information about potential safety issues. However, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has requested additional information and is currently reviewing post-marketing adverse event reports with Spiriva. In addition, the manufacturer of Spiriva has conducted a large study called UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), which is a large four year study that will provide additional long term safety data with Spiriva and additional insight into the risk of stroke or other safety findings with tiotropium. The data from UPLIFT is expected to be available in June 2008. Once Boehringer Ingelheim provides FDA with the UPLIFT study data, FDA will analyze the data and communicate its conclusions and recommendations to the public.
Spiriva HandiHaler is an effective medicine that is indicated for the long-term, once daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Patients should not stop taking Spiriva HandiHaler before talking to their doctor if they have questions about this new information.
The FDA urges both healthcare professionals and patients to report side effects from the use of Spiriva HandiHaler to the FDA's MedWatch Adverse Event Reporting program

online at www.fda.gov/medwatch/report.htm;
by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787;
faxing the form to 1-800-FDA-0178; or
by phone at 1-800-332-1088
****************************************************************************************************************
UPDATED DRUG SAFETY AND WARNING INFORMATION -(TUSSIONEX PENNKINETIC SUSPENSION -EXTENDED RELEASE -HYDROCODONE - LONG-ACTING COUGH PRODUCT)

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

[UPDATE 04/24/2008]Healthcare Professional Letter issued by UCB, Inc.

[Posted 03/11/2008] FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

FDA Public Health Advisory
Important Information for the Safe Use of
Tussionex Pennkinetic Extended-Release Suspension

FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important information on the safe and appropriate use of Tussionex Pennkinetic Extended-Release Suspension. Tussionex is a prescription cough medicine containing hydrocodone and the antihistamine, chlorpheniramine that is made to be given every 12 hours (“extended-release”). Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old.
FDA is highlighting the following important information on the safe use of Tussionex:

Do not give to children less than 6 years old. FDA has received reports of death due to respiratory depression with use of Tussionex in patients less than 6 years old.

Healthcare professionals should not prescribe and patients should not take Tussionex more often than every 12 hours. Taking this cough medicine more often than every 12 hours may result in a narcotic overdose. Too much hydrocodone can cause life-threatening breathing problems and death. If the cough is not controlled when taking Tussionex every 12 hours, talk to your doctor before taking more.

Healthcare professionals who prescribe and patients who use Tussionex should be aware of the signs of hydrocodone overdose including the following: trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients, parents, or caregivers should get medical attention right away.

Patients and parents should use a device designed to accurately measure Tussionex. Household teaspoons or tablespoons vary in size and can result in giving too much of the medicine. Use a syringe or spoon specifically designed to measure liquid medicine.
FDA has received reports of death and life-threatening side effects in patients, including children, who have received Tussionex. The reports indicate that doctors have inappropriately prescribed this medicine for patients less than 6 years old and at doses more frequent than every 12 hours. In addition, parents and caregivers have given this medicine too frequently and have not carefully measured the suspension, resulting in overdoses. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening breathing problems and death.
FDA has worked with the manufacturer of Tussionex Pennkinetic Extended-Release Suspension, UCB, to update the label, including information that Tussionex is not to be prescribed or used in children less than 6 years old and the need for accurate measurement and dosing.
There are cough products containing hydrocodone that can be given every 4 to 6 hours. FDA is reviewing safety information for these products and will provide updates as new information is available.